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In Vitro Diagnostics News

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286-300 of 2977 results
Ignyta gets FDA IDE approval for Trailblaze Pharos companion diagnostic assay
By MDBR Staff Writer
Ignyta has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Trailblaze Pharos RNA-based companion diagnostic and next-generation sequencing (NGS) assay.
Diagnostics > In Vitro Diagnostics > News
Exalenz, Conatus partner to use BreathID test in emricasan trial
Exalenz Bioscience has partnered with Conatus Pharmaceuticals to provide its BreathID Methacetin breath test (MBT) for monitoring patients in a planned Phase IIb clinical trial, which is assessing emricasan.
Diagnostics > In Vitro Diagnostics > News
Roche Zika test secures FDA emergency use authorization
By MDBR Staff Writer
Roche has received emergency use authorization (EUA) status from the US Food and Drug Administration (FDA) for its LightMix Zika rRT-PCR test.
Diagnostics > In Vitro Diagnostics > News
Chembio wins US Government contract to develop point-of-care tests for Zika Virus
By MDBR Staff Writer
Chembio Diagnostics has received a contract from the US Government to develop and commercialize point-of-care tests for Zika Virus.
Diagnostics > In Vitro Diagnostics > News
Rosetta Genomics selected by global pharmaceutical firm to supply FISH testing services for clinical study in prostate cancer
Rosetta Genomics, a leading developer and provider of microRNA-based and other molecular diagnostics, announces that the Company has entered into a services agreement with an unnamed global pharmaceutical company to provide Fluorescence in Situ Hybridization (FISH) testing services for a clinical study the pharmaceutical company is conducting in prostate cancer.
Diagnostics > In Vitro Diagnostics > News
OraSure secures US contract to accelerate development of Zika test
By MDBR Staff Writer
OraSure Technologies has secured a US government contract to accelerate the development of its oral test kits for the Zika virus.
Diagnostics > In Vitro Diagnostics > News
Interpace Diagnostics introduces new pancreatic cancer testing product
Interpace Diagnostics Group has introduced a new version of its AccuCEA product dubbed Insights for pancreatic cancer testing.
Diagnostics > In Vitro Diagnostics > News
AYOXXA and Märzhäuser introduce benchtop device for protein multiplex analysis
AYOXXA Biosystems, an international biotechnology company, and Märzhäuser Wetzlar GmbH & Co KG, a leading precision equipment manufacturer, joined forces to develop a dedicated benchtop device for the analysis of LUNARIS™ Multiplex assays.
Diagnostics > In Vitro Diagnostics > News
Corgenix transfers viral diagnostics business to Zalgen Labs
By MDBR Staff Writer
Corgenix Medical has transferred its viral hemorrhagic fever diagnostics business to Zalgen Labs, which is a member of the Viral Hemorrhagic Fever Consortium (VHFC).
Diagnostics > In Vitro Diagnostics > News
WHO accepts altona’s diagnostic test for Zika Virus
By MDBR Staff Writer
The World Health Organization (WHO) has accepted altona Diagnostics’ RealStar Zika Virus RT-PCR Kit 1.0 as in vitro diagnostic test.
Diagnostics > In Vitro Diagnostics > News
Akers Biosciences reveals results of BreathScan OxiCheck test
By MDBR Staff Writer
Akers Biosciences has revealed the results of a study related to its BreathScan OxiCheck test, designed to determine the levels of oxidative stress in the body.
Diagnostics > In Vitro Diagnostics > News
BioNTech, Shuwen get CFDA innovative medical product status for MammaTyper test
By MDBR Staff Writer
BioNTech Diagnostics and Shuwen Biotech have secured innovative medical product status from the China Food and Drug Administration (CFDA) for the MammaTyper PCR kit for breast cancer stratification.
Diagnostics > In Vitro Diagnostics > News
Alere i RSV rapid molecular test gets FDA approval
By MDBR Staff Writer
Alere has received 510(k) clearance from the US Food and Drug Administration (FDA) for its i RSV rapid molecular test.
Diagnostics > In Vitro Diagnostics > News
Quest Diagnostics approved to use electronic drug test process for federally-mandated workforce by US Health and Human Services
Quest Diagnostics (DGX), the world's leading provider of diagnostic services, announced that the U.S. Department of Health and Human Services (HHS) has authorized the company to perform drug testing using electronic Custody and Control Forms (eCCF) for federally-mandated, safety-sensitive workers.
Diagnostics > In Vitro Diagnostics > News
Vela Diagnostics gets CE mark approval for Zika Virus real-time PCR assay
Singapore-based Vela Diagnostics has received CE mark approval for its Zika Virus real-time PCR assay.
Diagnostics > In Vitro Diagnostics > News
286-300 of 2977 results